Orthopedic device

ABSTRACT

A compliance assembly includes a compliance strap arranged to engage and extend around the exterior of an orthopedic device, and a compliance clasp attached to the compliance strap. The compliance clasp includes a base member, a door member, and a locking system. The door member is pivotally connected to the base member and is movable between an open position and a closed position in which the door member is rotated toward the base member and locks the compliance strap between the base and door members. The locking system is arranged to irreversibly lock the door member in the closed position.

TECHNICAL FIELD

The disclosure relates to an orthopedic device for protecting and/orimmobilizing one or more affected areas on a user's lower leg, ankle,and/or foot.

BACKGROUND

It is common that people, especially frail elderly people and diabetics,experience a variety of lower leg, ankle, and foot injuries. Physicianstraditionally have treated, and still currently treat, injuries such aspressure ulcers affecting the foot by fitting the injured patient withthe well-known, molded plaster or resin cast. The placement of this typeof cast is time consuming, heavy, and costly. Further, this type of castmust not come into contact with water, which makes patient bathingdifficult and time consuming. Additionally, if the cast needs to beremoved for any reason, for example, inspection, a whole new cast mustbe prepared and applied.

Alternatively, walking boots or walkers have been used for protectingand immobilizing injured or affected areas of the lower leg, ankle,and/or foot, such that at least partial mobility may be maintained whilethe affected areas are in the process of healing. Further, in contrastto the molded plaster or resin cast, a walker can be easily removed inorder to bathe or for inspection of the injured limb by a physician orpractitioner.

Existing wrap-around or circumferential walkers however can be bulky anduncomfortable for users. Particularly, hard edges and/or surfaces ofexisting walkers can cause pressure points on the user's toes, feet,ankle, and/or lower leg that can cause users pain and discomfort, andmay also cause injury to a user, such as pressure ulcers. Pressureulcers can become infected, contain scar tissue, and may result insecondary problems up to and including amputation.

Alternatively, existing walkers may include inflatable supports forimproving the comfort of the walker, but these inflatable supports canbe more harmful than helpful. Particularly, existing walkers require theuser to regulate or control the pressure level in the inflatablesupports. This is problematic because patients, especially those withdiabetes, often experience reduced sensation in their extremities, whichcan result in them inadvertently overinflating the inflatable supports.Over-inflation of the inflatable supports can cause pressure on the skinwhich can reduce both capillary blood flow to the skin and arterial flowto the affected limb. It can also lead to the formation of pressureulcers on the foot of the patient and longer healing times for existingulcers. Further, existing walkers with inflatable supports often requirepatients to monitor pressure levels in the inflatable supports with apressure gauge. However, many patients do not see well enough to readthe pressure gauges and such pressure gauges are also known tomalfunction.

Additionally, features associated with the inflatable supports inexisting walkers are known to create pressure points within the walkerand/or to be unreliable. For instance, tubing associated with theinflatable supports is typically routed along the inside surface of thewalker, creating pressure points on the inside of the walker, which canbe uncomfortable and can cause additional pressure ulcers. Moreover,such tubing can become kinked and/or pinched between the walker and thepatient's lower leg, ankle, and/or foot, rendering the inflatablesupports effectively inoperable. Pump features associated with theinflatable supports are also commonly arranged on the walker such thatthey are prone to being bumped, misaligned, and/or damaged during use,increasing the likelihood that the inflatable supports will beinadvertently inflated, deflated, and/or rendered inoperable.

SUMMARY

The orthopedic device described herein may be, in exemplary embodiments,a lightweight walker. It is also contemplated that other orthopedicdevices may utilize similar configurations as described below.

The orthopedic device described herein typically takes the form of asemi-rigid or substantially rigid shell walker, which providesprotection and immobilization to an affected area on the lower leg,ankle, and/or foot by surrounding the lower leg, ankle, and/or foot withan appropriate structure. It will be recognized that the featuresdescribed herein may have applicability to other walker configurationsor other types of orthopedic devices.

In the exemplary embodiments, various configurations of flexible edgearrangements, inflation system arrangements, and shell arrangements areutilized to limit pressure points and/or excessive pressure on a user'slower leg, ankle, and/or foot in order to provide a more comfortable fitand more effective treatment of affected areas on the user's lower leg,ankle, and/or foot.

For example, an orthopedic device may include a base shell having ankleand foot receiving portions and forming an opening over a dorsal aspectof the base shell. A dorsal shell can be contoured to generallycorrespond to the opening in the base shell. The dorsal shell caninclude a proximal member connected to a distal member via a flexible orresilient connecting portion arranged to accommodate a portion of theuser's lower leg or ankle.

A first flexible edge portion can be attached to a distal terminal endof the distal member. During use, the distal member of the dorsal shellcan become pitched or angled relative to the user's toes due to avariety of different circumstances, including, but not limited to, useranatomy, use of heel lifts and/or wedges, or as the user walks. Thefirst flexible edge portion can be arranged to flex or bend relative tothe distal member when the distal member pitches or angles relative tothe toes. This has the effect of reducing the transfer of force from thedistal member to the toes and/or distributing the force from the distalmember over a greater surface area, which, in turn, reduces thelikelihood of a potentially harmful pressure point on the user's toesfrom the distal member.

The first flexible edge portion can also help accommodate bandaging ofthe user's toes or the forefoot because the first flexible edge portioncan be flexed upward or removed from the distal member. The firstflexible edge portion can also include a toe relief portion radiallyextending away from the user's toes, substantially reducing thelikelihood of the distal member diving down into the toes, which couldcause discomfort or even injury.

The proximal member of the dorsal shell may also include a secondflexible edge portion attached to a proximal terminal end of theproximal member. The second flexible edge portion on the proximal membercan be arranged to bend or flex when the user's leg exerts a force onthe second flexible edge portion. This has the effect of reducing thelikelihood of creating a pressure point on the user's lower leg from thedorsal shell and can provide pressure relief to the user's tibia,improving the comfort and effectiveness of the orthopedic device.

At least one observation hole may be formed in the base shell posteriorof the user's malleoli to allow for tactile confirmation of the positionof the user's foot within the orthopedic device, which can reduce thelikelihood of one or more pressure points within the orthopedic devicefrom the user's heel being too far back within the base shell.

By way of another example, an orthopedic device may include a base shelland a dorsal shell contoured to generally correspond to an opening inthe base shell. At least one tightening member can be connectable to thebase shell and extendable over the dorsal shell to secure the base shelland dorsal shell together about a user's lower leg and foot. At leastone inflatable bladder may be provided in the base shell and a pumpassembly may be arranged to inflate the at least one inflatable bladder.

The pump assembly can be situated on the at least one tightening membersuch that the position of the pump assembly is substantially fixedrelative to the base shell as the user walks in the orthopedic device.This advantageously limits unwanted movement of the pump assembly,reducing the likelihood of the pump assembly inadvertently inflating ordeflating the at least one inflatable bladder as in the prior art. Thepump assembly may also be situated on an anterior aspect of the at leastone tightening member, increasing the usability of the pump assembly.

The base shell can include at least one tube hole formed therein thatallows at least one inflation tube to pass from the pump assembly to anexterior surface of the base shell such that the at least one inflationtube can run along the exterior surface of the base shell rather thanthe interior of the base shell as in the prior art. This has the effectof reducing the likelihood of a pressure point from the at least oneinflation tube as the user walks in the orthopedic device and thelikelihood of the at least one inflation tube being pinched or kinkedinside of the orthopedic device.

A pressure relief valve assembly can be fluidly connected to the atleast one inflatable bladder and arranged to automatically release airfrom the at least one inflatable bladder to atmosphere when pressurewithin the at least one inflatable bladder exceeds a cracking pressureof the pressure relief valve assembly. This allows the pressure reliefvalve to automatically regulate or limit the pressure level within theat least one inflatable bladder rather than requiring the user toregulate the pressure level, as in the prior art, eliminating orsubstantially decreasing the likelihood that a user will over-inflatethe at least one inflatable bladder. This is advantageous because usersof walkers and other orthopedic devices, especially diabetic patients,often experience reduced sensation in their extremities, which canresult in them inadvertently over-inflating the at least one inflatablebladder. Such over-inflation can cause pressure on the skin, which canreduce both capillary blood flow to the skin and arterial flow to theanatomical member. It can also lead to the formation of pressure ulcerson the foot of the patient and longer healing times for existing ulcers.

Further, because the pressure relief valve automatically regulatespressure within the at least one inflatable bladder, users can inflatethe at least one inflatable bladder without the need of reading apressure gauge as in the prior art, making the orthopedic device easierand safer to use. The pressure relief valve assembly also overcomesissues with changes in ambient pressure creating excessive pressurewithin the at least one inflatable bladder, such as a change inaltitude, as the pressure relief valve assembly automatically reducesexcess pressure in the at least one inflatable bladder.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects, and advantages of the presentdisclosure will become better understood regarding the followingdescription, appended claims, and accompanying drawings.

FIG. 1 is a front side isometric view of an orthopedic device comprisinga walker according to an embodiment.

FIG. 2 is a back side isometric view of the walker shown in FIG. 1.

FIG. 3 is a detail view of an eyelet shown in FIG. 2 according to anembodiment.

FIG. 4 is a front isometric view of a hook tab component according to anembodiment.

FIG. 5 is a back isometric view of the hook tab component shown in FIG.4.

FIG. 6 is a back isometric view of the hook tab component and atightening tool according to another embodiment.

FIG. 7 is a front side isometric view of the base shell shown in FIG. 1.

FIG. 8A is a front side isometric view of the dorsal shell shown in FIG.1.

FIG. 8B is a partial front side isometric view of the dorsal shell shownin FIG. 8A.

FIG. 9 is a back side isometric view of the dorsal shell shown in FIG.1.

FIG. 10 is a front isometric view of a walker according to anotherembodiment.

FIG. 11 is a front isometric view of a compliance clasp assembly in aclosed position according to another embodiment.

FIG. 12 is a partial front isometric view of a compliance clasp in anopen position according to an embodiment.

FIG. 13 is a sectional view of the compliance clasp shown in FIG. 12taken along section line 12-12.

FIG. 14 is a front isometric view of a compliance clasp in an openposition according to another embodiment.

FIG. 15 is a front isometric view of a walker according to anotherembodiment.

FIG. 16 is a back isometric view of the walker shown in FIG. 15.

FIG. 17 is a schematic view of an air inflation system for use with thewalker shown in FIG. 15 according to an embodiment.

FIG. 18 is an exploded view of a pump assembly according to anembodiment.

FIG. 19 is an exploded view of a pump assembly according to anotherembodiment.

FIG. 20 is a partial side view of the walker shown in FIG. 15.

FIG. 21 is a partial exploded back view of the walker shown in FIG. 15.

FIG. 22 is a side isometric view of the pressure relief valve assemblyshown in FIG. 21.

FIG. 23 is a cross sectional view of the pressure relief valve assemblyshown in FIG. 22.

FIG. 24 is a side isometric view of a pressure relief valve assemblyaccording to another embodiment.

FIG. 25 is a cross sectional view of the pressure relief valve assemblyshown in 24.

FIG. 26 is an isometric view of a pressure relief valve assembly andcover member according to another embodiment.

FIG. 27 is a front view of the base shell shown in FIG. 15 with theliner removed, showing the bladder.

FIG. 28 is a schematic diagram of an inflation system according toanother embodiment.

DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS

A better understanding of different embodiments of the disclosure may behad from the following description read with the accompanying drawingsin which like reference characters refer to like elements.

While the disclosure is susceptible to various modifications andalternative constructions, certain illustrative embodiments are in thedrawings and described below. It should be understood, however, there isno intention to limit the disclosure to the embodiments disclosed, buton the contrary, that the intention covers all modifications,alternative constructions, combinations, and equivalents falling withthe spirit and scope of the disclosure.

For further ease of understanding the embodiments of an orthopedicdevice as disclosed herein, a description of a few terms is necessary.As used herein, the term “dorsal” has its ordinary meaning and refers tothe top surfaces of the foot, ankle and foreleg or shin. As used herein,the term “plantar” has its ordinary meaning and refers to a bottomsurface, such as the bottom of a foot. As used herein, the term“proximal” has its ordinary meaning and refers to a location that iscloser to the heart than another location. Likewise, the term “distal”has its ordinary meaning and refers to a location that is further fromthe heart than another location. The term “posterior” also has itsordinary meaning and refers to a location that is behind or to the rearof another location. Lastly, the term “anterior” has its ordinarymeaning and refers to a location that is ahead of or to the front ofanother location.

The terms “rigid,” “flexible,” and “resilient” may be used herein todistinguish characteristics of portions of certain features of theorthopedic device. The term “rigid” is intended to denote that anelement of the device is generally devoid of flexibility. Within thecontext of support members or shells that are “rigid,” it is intended toindicate that they do not lose their overall shape when force isapplied, and in fact they may break if bent with sufficient force. Onthe other hand, the term “flexible” is intended to denote that featuresare capable of repeated bending such that the features may be bent intoretained shapes or the features do not retain a general shape, butcontinuously deform when force is applied. The term “resilient” is usedto qualify such flexible features as generally returning to an initialgeneral shape without permanent deformation. As for the term“semi-rigid,” this term is used to connote properties of support membersor shells that provide support and are free-standing; however suchsupport members or shells may have some degree of flexibility orresiliency.

An exemplary embodiment of a walker 100 is shown in FIGS. 1-9. As can beseen from the figures this embodiment includes complementary base 102and dorsal 104 shells that are selectively engageable with each other inorder to provide easy access to the interior of the device for ease ofdonning and doffing the device, in particular for donning and doffingthe device unto an injured limb. The base shell 102 has ankle and footreceiving portions 101, 103 (best shown in FIG. 7) and forms an opening105 (best shown in FIG. 7) over a dorsal aspect thereof. The dorsalshell 104 is contoured to generally correspond to the opening 105 of thebase shell 102.

The walker 100 can include a semi-rigid or substantially rigid shellconfiguration that is formed to support and support the lower leg, foot,and ankle of the user or patient. The shell configuration can extendfrom the foot and ankle up along the shin and tibia of the lower leg toa desired point below the knee joint. Exemplary suitable materials forforming the shells can include metals, such as aluminum, carbon,composites, glass fiber/epoxy composites, or suitable plastic materials,such as thermoplastic or thermosetting polymers, fiber reinforcedplastic, molded chopped fibers, or any other suitable material. Otherexemplary materials include, but are not limited to, nylons, glassfilled nylon, polypropylenes, vinyls, polyvinyl chlorides, high densitypolyethylene, epoxies, urethanes, and polyesters. While the walker isdescribed having a rigid shell configuration, it will be appreciatedthat the walker 100 may be any type of walker or other suitableorthopedic device.

In use, a user can move the walker 100 from a closed configuration to anopen configuration by moving the dorsal shell 104 away from the baseshell 102, allowing insertion of the lower leg, ankle, and foot into thewalker 100. Once the user has inserted their lower leg into the walker100, the dorsal shell 104 can be returned to the closed configuration toenclose the lower leg within the walker 100. The user can then utilizeone or more tightening mechanisms described below to apply pressure andsupport and to maintain the walker 100 in the closed configuration.

The walker 100 can be oversized to accommodate a number of differentaccessory components and/or sized feet. A width of the walker 100 can bedefined between the lateral and medial sides of the walker 100. Thewidth of the walker 100 can be between about 1.02 and about 1.5, betweenabout 1.05 and about 1.3 (e.g., about 1.08), or between about 1.1 andabout 1.2 times greater than the width of a conventional walker. Forinstance, if a conventional walker has a width of about 140 mm, thewalker 100 can have a width between about 145 mm and about 160 mm (e.g.,about 152 mm). This has the effect of providing a larger foot bed withinthe walker 100 for insertion of accessory components, such as, but notlimited to, heel wedges, inflatable bladders, padding, or other suitablecomponents. This also allows the walker 100 to accommodate larger feetand/or to be a multi-purpose walker. For instance, the oversized footbed can provide sufficient space to add and/or remove components fromthe walker 100, allowing the walker 100 to be customized for a specificpurpose. More particularly, by adding and/or removing components fromthe foot bed of the walker 100, the walker 100 can be converted from onetype of walker to another type of walker (e.g., from a diabetic walkerto an Achilles walker, or a fracture walker, or vice versa).

The shell configuration includes a base shell 102 and a dorsal shell104. At least one of the base shell 102 or the dorsal shell 104 can havegenerally smooth rounded edges, helping to increase the comfort andsafety of the walker 100. The base shell 102 has a posterior portion 106(best shown in FIG. 2) and a plantar portion 108 that is arranged toextend along the plantar surface of the foot. Lateral and medial (firstand second) wing portions 110 extend from the posterior portion 106 andthe plantar portion 108. The wing portions 110 can be arranged to atleast partially enclose and support a user's leg. A soft good liner 112can be situated inside the base shell 102. An insole 114 can be providedon the proximal surface of the liner 112 and/or the base shell 102. Anoutsole 116 is formed on the base shell 102, either integrally, orseparately. The outsole 116 can define a toe protector portion 118 andcan have any suitable configuration, such as a rubber sole having a rollover shape.

In order to reduce the weight of the walker 100 and/or to provideventilation, material can be removed from areas of the shell portions toprovide apertures 120. The apertures 120 can be formed in any of theshells 102, 104. The apertures 120 can have different sizes and/orshapes. The apertures 120 can extend at an angle. For instance, some ofall of the apertures 120 can have a generally oblong shape and canextend at an angle. The apertures 120 in the ankle region of the baseshell 102 can be longer than the apertures 120 in a toe region of thebase shell 102.

Some or all of the apertures 120 can be arranged in one or moregradients. Arranging the apertures 120 in gradients can improve thebiomechanical properties of the shells with respect to an anatomicallimb positioned in the walker 100 by influencing the flexibility orstiffness of the shells with the apertures. For instance, the apertures120 in the foot receiving portion 103 of the base shell 102 can bearranged in a gradient with larger apertures 120 in the ankle region andsmaller apertures in the toe region. The apertures 120 in an upperregion of the base shell 102 can be arranged with larger apertures 120toward the middle of the lower leg and smaller apertures 120 toward theankle and the knee.

In other embodiments, the apertures 120 in the upper region of the baseshell 102 can have different sizes and shapes and can be extending at anangle. Some or all of the apertures 120 can also be arranged in aplurality of rows. Some or all of the apertures 120 in the footreceiving portion 103 of the base shell 120 can comprise a series ofslots extending at an angle and a singular larger, irregularly shapednon-through hole in the toe region.

The apertures 120 can comprise through holes and/or non-through holes.Some or all of the apertures 120 in the foot receiving portion 103 ofthe base shell 102 can be non-through holes. This can prevent ingress ofexternal objects through the apertures 120 that may potentially injurethe foot, which, in turn, enhances user safety. This also has the effectof protecting the user's foot from sharp edges that can injure the foot.The non-through holes in the foot receiving portion 103 are especiallyimportant for users of the walker 100 who suffer from neuropathy havingnerve damage in the foot. Non-through holes in either shell can alsoreinforce or strength the walker 100 in the region of the apertures 120.

Some or all of the apertures 120 can comprise through holes. Some or allof the through holes can be positioned, shaped, sized, and/or patternedto enhance heat and/or fluid transfer from the interior of the walker100 to the exterior of the walker 100. This can allow the walker 100 tovent heat and/or perspiration from the interior of the walker 100,which, in turn, increases user comfort. The through-holes can alsoprovide some level of resiliency to the shells. This can allow thewalker 100 to better accommodate swelling of a limb or different sizesof lower legs, ankles, and/or feet.

Some or all of the apertures 120 can include a through-hole portion anda non-through hole portion. For instance, some or all of the apertures120 can include a periphery and upstanding sidewall portions extendingabout the periphery. A non-through hole portion can include a bottomsurface formed by a portion of the shell and a through-hole portion canbe open ended, extending completely through the shell.

Some or all of the apertures 120 can include radiused or rounded-offedges, reducing the likelihood of a user inadvertently scrapping orinjuring a non-affected limb on the edges of the apertures 120 as thenon-affected limb moves back and forth across the apertures.

The walker 100 can have structures designed to selectively strengthenthe base shell 102 and the dorsal shell 104 in a specific direction. Thebase shell 102 can include reinforcing ridges 121 that extend at anangle along both lateral and medial sides thereof.

As can be seen in FIGS. 1 and 2, eyelets 122 can be formed in the wingportions 110 of the base shell 102 for providing one or more anchoringpoints for different components and/or accessories. FIG. 3 is a detailedview of an eyelet 122 according to an embodiment.

The eyelet 122 can include an annular rim portion 124, a sloping innersidewall portion 126, a through-hole portion 128, and a seat 130 formedin the inner sidewall portion 126 for receiving and securing a portionof an attachment system (e.g., a hook portion) therein. The eyelets 122can be at least partially debossed below an exterior surface of the baseshell 102 such that each eyelet 122 is at substantially the same depthbelow the exterior surface.

Some or all of the eyelets 122 can provide an anchoring a point for ahook tab component, such as the hook tab component 132 shown in FIGS. 4and 5. As seen, the hook tab component 132 can comprise a largergenerally elliptical main body 134, a smaller portion 136, a generallyplanar bottom side 138, and an upper side 140. The hook tab component132 can be formed from any suitable material such a plastic, rubber, ormetal material.

The bottom side 138 of the hook tab component 132 can arranged toprovide an attachment surface for a portion of a hook-and-loop typesystem (e.g., Velcro®), the liner 112, a pad, an inflatable bladderdescribed below, or any other suitable component. The attachment surfacecan be used to place an adhesive dot or two sided tape on the hook tabcomponent 132. For instance, a pad could be adhered to the bottom side138 of the hook tab component 132 via the adhesive dot or two sided tapeand then secured in a fixed position on the walker 100 as desired.

A hook member 142 can be formed on the upper side 140 for interfacingwith an eyelet 122. The hook member 142 can exhibit any suitableconfiguration. The hook member 142 can include a generally rectangularbase portion attached to the upper side 140 and a generally oblong headportion attached to the rectangular base portion.

The hook member 142 can anchor the hook tab component 132 to the baseshell 102. The hook tab component 132 can be situated inside the walker(shown in FIG. 7) and the head portion of the hook member 142 can begenerally aligned with the through-hole portion 128 in the eyelet 122.The head portion of the hook member 142 can then be inserted through thethrough-hole portion 128 and rotated until the head portion of the hookmember 142 rests in the seat 130 of the eyelet 122, which secures thehook tab component 132 within the eyelet 122. While secured in theeyelet 122, the upper side 140 of the hook tab component 132 can befacing and/or secured against the interior surface of the base shell102. This allows the location of components inside of the walker 100 tobe customized by installing hook tab components 132 attached orattachable to the components in different eyelets 122 formed in the baseshell 102.

Optionally, the hook tab component 132 can include installation featuresto aid in the installation of the hook tab component in the eyelet 122.FIG. 6 illustrates a hook tab component 232 according to anotherembodiment including a recessed portion 244 formed in the bottom side238 of the smaller portion 236.

A user can insert a tightening tool 246 or key within the recessedportion 244 to rotate the hook tab component 232 within the eyelet 122relative to the base shell 102. A first portion of the tightening tool246 can be positioned on the bottom side 238 at or near a center of thehook tab component 232. A protrusion 247 on the tightening tool 246 canbe positioned in the recessed portion 244. The tightening tool 246 canthen be rotated about the first portion on the center of the hook tabcomponent 232, which, in turn, causes the protrusion to engage ashoulder formed by the recessed portion 244, rotating the hook tabcomponent 232. This can facilitate installation of the hook tabcomponent 232 in the eyelet 122. Requiring the use of the tighteningtool 246 can help deter a patient or user from removing or moving thehook tab components 232, and thereby components attached thereto, fromthe walker 100 without the consent of a clinician or medicalprofessional. The tightening tool 246 can also be provided to theclinician or medical professional but not the user or patient, helpingto prevent tampering.

Referring again to FIG. 2, a flexible or resilient edge portion 148 andexpansion joints 150 can be formed on the posterior portion 106 of thebase shell 102 along the edges of and between the posterior of the wingportions 110. The expansion joints 150 can be arranged in discretegroupings and formed having a larger dimension at the proximal end andtapering down to a smaller dimension at the distal end. The expansionjoints 150 can include any number of expansion holes 151 passingtherethrough. The expansion holes 151 can be arranged in any suitablemanner and can have any desired shape or size.

Some or all of the expansion joints 150 and/or the flexible edge portion148 can be formed via overmolding a different material onto end portionsof the base shell 102. For instance, the flexible edge portion 148 canbe formed via a flexible plastic or elastomer, such as, for example,thermoplastic elastomer (TPE), rubber, or ethylene vinyl acetate (EVA)foam. In other embodiments, any other suitable material may be utilized,including silicone or natural or synthetic fibers. Overmolds andovermolding techniques are described in more detail in U.S. Pat. No.5,951,504, granted Sep. 14, 1999, U.S. Pat. No. 7,018,351, granted Mar.28, 2006, U.S. Pat. No. 7,288,076, granted Oct. 30, 2007, U.S. Pat. No.7,311,686, granted Dec. 25, 2007, and U.S. Pat. No. 8,002,724, grantedAug. 23, 2011, all of which are incorporated herein, in their entirety,by this reference.

One or more observation holes 152 are formed in the wing portions 110 ofthe base shell 102 in the ankle receiving portion 101, allowing for easyobservation of the position of the user's foot within the walker 100and/or observation of the operation of one or more inflatable bladderswithin the walker 100. The observation holes 152 can exhibit anysuitable configuration. The observation holes 152 can comprise generallyrounded triangular through-holes positioned posterior to the malleoli inthe base shell 102. The position, size and shape of the observationholes 152 can be arranged for tactile confirmation of the position ofthe foot within the walker 100. Using the observation holes 152 aclinician, medical professional, or user can confirm that the heel ofthe user is properly positioned within the walker 100, which, in turn,reduces the likelihood of pressure points within the walker 100 from theheel being too far back.

Wounds in the ankle region of the user's foot can be observed via theobservation holes 152 without the need of removing the walker 100 fromthe foot, increasing the convenience of the walker 100. The observationholes 152 can also allow for tactile and/or visual confirmation thatinflatable bladders positionable inside the base shell 102 are properlyinflating or inflated, decreasing the likelihood of improper inflation.

While the observation holes 152 are described as generally triangular,it will be appreciated that the observation holes 152 can be generallycircular, generally oval, generally diamond, or any other suitableshape. Further, while two observation holes are shown, in otherembodiments, the walker 100 can include one, three, four, or any othersuitable number of observation holes. The observation holes 152 can alsobe formed in any portion of the walker 100.

As best seen in FIGS. 1, 2 and 7, a plurality of tightening mechanisms154 can be arranged to bring the base shell 102 and the dorsal shell 104closer together for tightening the walker 100 around the lower leg,ankle, and the foot. The plurality of tightening mechanisms 154 caninclude an ankle strap 154A, an upper strap 154B, and a foot strap 154C.

The ankle strap 154A can be arranged to cross over the ankle and tosubstantially fix the position of the ankle relative to the walker 100.The upper strap 154B can be arranged to cross over the lower leg belowthe knee. The upper strap 154B in concert with the ankle strap 154A cansubstantially fix the position of the lower leg relative to the baseshell 102 by forming at least two anchoring points, one over the ankleand the other below the knee. The foot strap 154C can be arranged tocross over the dorsal aspect of the foot. The foot strap 154C in concertwith the ankle strap 154A can substantially fix the position of the footrelative to the base shell 102 by forming at least two anchoring points,one over the ankle and one over the distal aspect of the foot. Thearrangement of the straps 154 help to keep the foot and/or ankle frommoving around in the foot bed of the walker 100 reduces the likelihoodof sores forming on the plantar surface of the foot, ankle, and/or lowerleg from unwanted movement of the same within the walker 100.

The straps 154 can comprise any suitable material. The straps 154 caninclude woven materials, cotton, foam, rubber, nylon, polyesters,neoprene, vinyl, webbing, or any other suitable material. The straps 154can include any suitable type of fastening system. The straps 154 caninclude corresponding hook-and-loop fasteners so that at least an endportion of the straps 154 can connect a strap 154 to itself. A loop orD-ring can be attached to one end portion of the strap 154, allowing thestrap 154 to be looped through the loop or D-ring and attaching toitself via any suitable fastener.

A plurality of strap slots 156 can be formed in the wing portions 110and the posterior portion 106 of the base shell 102 for receiving andpositioning the straps. Strap connecting portions 158 can be provided onthe wing portions 110 for anchoring the straps 154 on the base shell102. The strap connecting portions 158 can comprise reduced thicknessportions, holes for rivet connections, or other suitable structure. Ifholes or rivet connections are used, connections points for the straps154 can be pivotable. For instance, an end portion of some or all of thestraps 154 can include one or more grommets arranged to receive one ormore rivets, forming a riveted connection between the strap and the baseshell 102, allowing the strap to rotate at least some degree relative tothe base shell 102.

A loop or D-ring 160 can be attached to one end of the upper strap 154B.The upper strap 154B can be threaded through the strap slots 156 on thewing portions 110 of the base shell 102 and the strap slots 156 on theposterior portion 106 of the base shell 102. The upper strap 154B canthen be looped through the loop or D-ring 160 and attached to itself,securing the upper strap 154B over the dorsal shell 104.

Loops or D-rings 160 are attached via loops of fabric that are attachedto the strap connecting portions 158 on one of the wing portions 110 inthe foot receiving portion 103 via loops of fabric. Each of the anklestrap 154A and the foot strap 154C can be connected at one end to thestrap connecting portions 158 on the opposite wing portion 110. Tofasten the ankle strap 154A and the foot strap 154C over the dorsalshell 104, the straps 154A, 154C can be extended across the dorsal shell104 and free ends thereof can be looped through the loops or b-rings 160on the opposite wing portion 110. Each of the ankle strap 154A and thefoot strap 154C can then be connected to itself via any suitablefastener, such as hook-and-loop fasteners. Alternatively, the loops orD-rings in the foot and/or ankle region can be omitted. For instance,the ankle strap 154A and the foot strap 154C can be attached to the wingportions 110 via strap slots formed in the wing portions 110.

Strap slots 156 can be formed medial and lateral of the foot receivingportion 103 in the base shell 102. The foot strap 154C and theconnection of the loop or D-ring 160 in this region pass from the strapconnecting portions 158 on the interior of the base shell 102 throughthese strap slots 156 to the exterior of the base shell 102, situatingthe foot strap 154C on the outside of the base shell 102. The foot strap154C can thus be accessible on the exterior of the base shell 102 ratherthan the interior of the base shell 102, as in the prior art. Thisallows a user to more easily locate and/or thread the foot strap 154Cthrough the loop or D-ring 160 and reduces the likelihood of the footstrap 154C failing inside of the walker 100, making the walker 100easier to don and doff. Further because the foot strap 154C is on theoutside of the base shell 102, the likelihood of pressure points formingalong the dorsal surface of the user's foot from the foot strap 154C issignificantly reduced, making the walker 100 safer and more comfortableto wear.

The number and configuration of the straps 154 is to be regarded asexemplary only, as any suitable number and/or configuration oftightening mechanisms is possible. For instance, the walker 100 caninclude two, four, or any other suitable number of straps. In place ofstraps, other suitable tightening mechanisms, such as buckles or quickconnecting strap mechanisms can be utilized.

Referring to FIGS. 8A-9, the dorsal shell 104 can be formed either in asingle piece or in multiple portions. The dorsal shell 104 can include aproximal member 162 and a distal member 164 connected to the proximalmember 162 via a flexible or resilient connecting portion 166. Aplurality of apertures 120 are formed in the distal member 164 of thedorsal shell 104. The apertures 120 can be slanted and can include agenerally oblong periphery. The apertures 120 can be arranged in a firstcolumn on one side of a longitudinal axis of the distal member 164 and asecond column on the opposite side of the longitudinal axis. Some or allof the apertures 120 can have rounded or curved edges, protecting anunaffected limb from being scratched or cut by the edges of theapertures 120.

Some or all of the apertures 120 in the distal member 164 can benon-through holes, preventing ingress of external objects (e.g., debris,gravel, sand) through the apertures 120 that could injure the foot ofthe user. The non-through holes can further help protect the foot fromsharp edges and/or objects. It will be appreciated that some or all ofthe apertures 120 in the distal member 164 can be through-holes oromitted.

A flexible edge or flexible toe portion 168 can be attached to a distalterminal end of the distal member 164 for reducing the likelihood ofpressure points from the dorsal shell 104 in the toe region of theuser's foot. The flexible toe portion 168 extends between the medial andlateral sides of the distal member 164. The flexible toe portion 168 caninclude a periphery, an upper surface area, a distal sidewall portion,and a proximal sidewall portion extending from the upper surface area.The flexible toe portion 168 can be formed of any suitable material. Theflexible toe portion 168 can be formed of a flexible plastic orelastomer, such as for example, rubber or EVA foam. Other suitablematerials may include silicone or natural or synthetic fibers.

During use, the dorsal shell 104 can become pitched or angled relativeto the user's toes, forcing the distal member 164 and the flexible toeportion 168 onto the toes. The distal member 164 can become pitched orangled relative to the toes due to a variety of different circumstances.For instance, the distal member 164 can become pitched or angledrelative to the toes by user anatomy (e.g., high instep) or with the useof heel lifts and/or wedges. By way of another example, the distalmember 164 can become pitched or angled relative to the toes as the userwalks.

As the distal member 164 pitches or angles relative to the user's toes,the flexible toe portion 168 can bend or flex relative to the distalmember 164. This has the effect of reducing the transfer of force fromthe distal member 164 to the toes and/or distributing the force from thedistal member 164 over a greater surface area, which, in turn, reducesthe likelihood of pressure points forming on the toes from the distalmember 164. The flexible toe portion 168 can also help accommodatebandaging of the toes or the forefoot because the flexible edge portioncan be flexed upwards, cut, and/or removed from the distal member 164.The arrangement of the flexible toe portion 168 also provides a barrierover the toes, protecting the toes from external objects and/or sharpedges.

Optionally, a toe relief portion 170 of the flexible toe portion 168 canangle, curve upward, and/or radially extend away from the user's toes,spacing the toe relief portion 170 a distance away from the toes and/orcreating an axis other than the toe relief portion 170 about which theflexible toe portion 168 can flex. This has the effect of reducing thelikelihood of pressure points on the user's toes from the flexible toeportion 168. In addition, if the flexible toe portion 168 is forceddownward onto the toe protector portion 118 (shown in FIG. 1) of theoutsole 116, the upward angle of the toe relief portion 170 can allowthe flexible toe portion 168 to move up and away from the user's toesrather than diving down into the toes, which could cause discomfort oreven injury. The toe relief portion 170 can bend back away from the toesand toward an upper surface of the distal member 164. The upward angleof the edge portion 168 also can help create additional space toaccommodate the user's toes.

The flexible toe portion 168 can be attached to the distal member 164 ofthe dorsal shell 104 in any suitable manner. The flexible toe portion168 can be overmolded on a distal edge of the distal member 164 withalternating and/or intermeshing portions of the flexible toe portion 168and distal member 164 mechanically fastening the flexible toe portion168 and the distal member 164.

As best seen in FIG. 8B, a ridge portion 172 can be formed on an uppersurface of the distal member 164 for increasing the attachment strengthbetween the flexible toe portion 168 and the distal member 164. Theridge portion 172 can extend at least in part between the lateral andmedial sides of the distal member 164 adjacent the flexible toe portion168. The ridge portion 172 can be elongated, having a proximal sidewallportion, a distal sidewall portion, and an upper surface area extendingbetween the proximal and distal sidewall portions. The ridge portion 172can increase the attachment surface area between distal member 164 andthe flexible toe portion 168.

The flexible toe portion 168 can be attached to both the distal sidewallportion and the upper surface area of the ridge portion 172, increasingthe connection surface area between the distal member 164 and theflexible toe portion 168, which, in turn, increases the connectionstrength between the flexible toe portion 168 and the distal member 164.

The distal sidewall portion of the ridge portion 172 can physicallyblock the foot strap 154C (shown in FIG. 1) from sliding onto theflexible toe portion 168, increasing the protection of the user's toes.The ridge portion 172 preventing or limiting movement of the foot strap154C can also reduce the likelihood of the dorsal shell 104 beingprematurely worn down by a migrating foot strap 154C. The ridge portion172 further can reinforce the flexible toe portion 168. For instance, ifthe flexible toe portion 168 is forced into the toe protector portion118 (shown in FIG. 1) of the outsole 116, the distal sidewall portion ofthe ridge portion 172 can support the proximal sidewall portion of theflexible toe portion 168 against shear or other forces that couldpotentially cause the flexible toe portion 168 to tear away from thedistal member 164 of the dorsal shell 104. In other embodiments, theflexible toe portion 168 can be omitted.

Similar to the flexible edge portion, the connecting portion 166 betweenthe distal member 164 and the proximal member 162 can be arranged toflex or bend. The connecting portion 166 can flex or bend between theproximal member 162 and the distal member 164 as the proximal member 162and/or the distal member 164 move toward and/or away from one another.The proximal member 162 and the distal member 164 can be forced towardone another as the user walks or due to user anatomy or with the user ofheel lifts and/or wedges in the foot bed of the walker 100, or underother conditions.

By flexing between the proximal member 162 and the distal member 164,the connecting portion 166 can help reduce or eliminate the formation ofpressure points along the dorsal surface of a user's lower leg, ankle,or foot from the dorsal shell 104. Further, due to the flexible natureor resiliency of the connection portion 166, when the dorsal shell 104is closed around the user's lower leg, ankle or foot, different sizedanatomies can be accommodated using the same sized walker 100. Inaddition, the connecting portion 166 can help the dorsal shell 104automatically expand or contract due to swelling or reduction ofswelling in the lower leg, ankle, and foot of a user.

The connecting portion 166 can include a periphery, an upper generallycontinuous surface area and a pair of laterally upstanding, sidewallportions extending along two opposed sides of the upper surface area.The connecting portion 166 can further include a distal sidewall portionextending along an edge of the upper surface area and a proximalsidewall portion extending along an edge of the upper surface area. Theproximal sidewall portion can extend along an imaginary curved line thatdefines a peak near a center of the connecting portion 166.

As best seen in FIG. 9, the connecting portion 166 further includes alower generally continuous surface area opposed the upper surface area.At least a portion of the lower surface area can have a concavecurvature to help the connecting portion 166 fit over the ridge of thefoot and/or the ankle. The concave curvature of the connecting portion166 can allow the connecting portion 166 to be more comfortably arrangedalong the dorsal surface of the ankle and/or the foot of a user. Athickness defined between the upper and lower surface areas of theconnecting portion 166 can be arranged to provide cushioning and/orprotection to the ankle and/or foot.

The connecting portion 166 can be attached between the proximal member162 and the distal member 164 in any suitable manner. The connectingportion 166 may be formed via overmolding as discussed above. Theconnecting portion 166 can overlap a portion of the upper surface areasof the proximal member 162 and the distal member 164, increasing theconnection surface area between the connecting portion 166, the proximalmember 162, and the distal member 164.

Referring again to FIG. 8B, a ridge 174 is formed on the upper surfacearea of the proximal member 162 near a distal edge of the proximalmember 162. A ridge 176 is formed on the upper surface of the distalmember 164 near a proximal edge of the distal member 164. The connectingportion 166 extends between the ridge 174 and the ridge 176.

The ridge portion 174 can include an upper surface area, a distalsidewall surface attached to the connecting portion 166 and a generalshape that corresponds to the proximal sidewall portion of theconnecting portion 166. The ridge portion 176 can include an uppersurface area, a distal sidewall portion, and proximal sidewall portionattached to the connecting portion 166. As shown, the proximal sidewallportion of the ridge portion 176 can be curved such that the width ofthe ridge portion 176 between the proximal and distal sidewall portionsvaries.

The ridge portions 174, 176 can help maintain the position of the anklestrap 154A on the dorsal shell 104. When the strap 154A is tightenedover the connecting portion 166 across the ankle of the user (best shownin FIG. 1), the strap 154A can compress the connecting portion 166 to adegree such that the lower surface area of the strap 154A descends belowthe upper surface areas of the ridge portions 174, 176. This can allowthe distal sidewall portion of the ridge 174 and the proximal sidewallportion of the ridge 176 to limit proximal and distal movement of thestrap 154A.

The ridge portions 174, 176 can help prevent the strap 154A from digginginto the ankle of the user. The connecting portion 166 can be arrangedsuch that compressive pressure or forces exerted on the connectingportion 166 by the strap 154A are substantially transferred from theconnecting portion 166 to the ridge portions 174, 176, and the uppersurfaces of the distal member 164 and the proximal portion 166 ratherthan the ankle and/or the foot.

While the connecting portion 166 is described forming a hinge mechanismbetween the proximal member 162 and the distal member 164, alternativehinge mechanisms can be used, such as pivot pins and sleeves, piano orbutterfly hinges, or other suitable hinge mechanisms can be used inplace of the connecting portion 166. For instance, one or more malleablebars or bars (not shown) can connect the proximal member 162 and thedistal member 164. The bars can be arranged as a metal stay such that aclinician or medical professional can selectively bend the bars tochange or set the aspect ratio of the proximal and distal members 162,164 relative to one another. This can help accommodate treatment ofAchilles tendon injuries, for example, where heel wedges are selectivelypositioned within the foot bed of the walker 100 by a medicalprofessional to adjust the angle of the user's foot within the foot bed.Optionally, the bars can be enclosed within a protective covering suchas an overmold portion to provide a comfort fit.

Referring now to the proximal member 162 best shown in FIG. 8A, aplurality of apertures 120 can be formed in the proximal member 162. Theapertures 120 can exhibit any suitable configuration. The apertures 120can have a periphery having opposed parallel longitudinal sidewallportion and curved or rounded end wall portions. The apertures 120 canbe arranged in two columns extending at least a portion of the distancebetween the proximal edge of the proximal member 162 and the distal edgeof the proximal member 162. The columns can be located on opposite sidesof the longitudinal axis of the dorsal shell 104.

Some or all of the apertures 120 can be slanted with a through-holeportion and a non-through hole portion. For example, one or more of theapertures 120 can include two through-holes separated by a non-throughhole. Similar to the apertures in the base shell 102, the apertures 120can help venting by allowing air to flow into and out of thethrough-hole portion. The apertures 120 can help reduce the weight ofthe walker 100 by reducing the amount of material in the dorsal shell104. The apertures 120 also may help strengthen the dorsal shell 104 byreinforcing the proximal member 162 with the material remaining in thenon-through hole portion of the aperture 120.

A flexible or resilient edge portion 178 can be formed on the proximalterminal end of the proximal member 162. The flexible edge portion 178can exhibit any suitable configuration and can be formed via anysuitable technique as discussed above. The flexible edge portion 178 caninclude a periphery, a generally convex upper surface area, a distalsidewall portion attached to the proximal member 162, a proximalsidewall portion, and a generally concave lower surface area. The distalsidewall portion of the flexible edge portion 178 can extend along agenerally wavy line defining a valley in the tibial crest area of theuser.

The flexible edge portion 178 can bend or flex when the leg of the userpushes on the flexible edge portion 178. The flexible edge portion 178can bend or flex when the proximal member 162 becomes angled or pitchedtoward the user's lower leg. This can allow the flexible edge portion178 to act as an expansion mechanism to accommodate different sizedlower legs of different users, providing a comfortable fit for differentusers having different sized anatomies. The bending or flexing of theflexible edge portion 178 can also reduce and/or eliminate thelikelihood of pressure points on the tibia, increasing the comfort ofthe walker 100 and providing tibia relief.

Optionally, a tibia relief portion 180 of the flexible edge portion 178can angle, curve, or radially extend away from the other portions of theupper surface area of the flexible edge portion 178 or the user's leg,spacing the tibia relief portion 180 of the flexible edge portion 178 adistance away from the user's leg. This can provide additional space forthe tibial crest, allowing the flexible edge portion 178 to betteraccommodate the tibial crest as the user walks. This can also helpreduce the likelihood of pressure points or edge pressures on the leg ortibia from the dorsal shell 104. For instance, because the tibia reliefportion 180 extends away from the lower leg, as the user's lower legpushes against the flexible edge portion 178, the user's leg can bend orflex the flexible edge portion 178 further away from proximal member162, reducing pressure points or edge pressures on the leg from thedorsal shell 108. The tibia relief portion 180 can be arranged to bendaway from the leg and toward an outer surface of the proximal member162. In other embodiments, the flexible edge portion 178 can be omitted.

A compliance strap guide 182 can be formed on the dorsal shell foraccommodating a compliance strap. A compliance strap is a strap that canbe used to deter a user or patient from prematurely or frequentlyremoving a walker, which can disrupt the healing process of the foot.

Another exemplary embodiment of a walker 300 is shown in FIG. 10. Thisembodiment includes a base shell 302, a dorsal shell 304, and acompliance strap guide 382 can be positioned on an anterior aspect of aproximal member 362 of the dorsal shell 304. A compliance strap assembly384 can comprise a compliance strap 386 arranged through the compliancestrap guide 382 and irreversibly attached to itself via an adhesive.When the compliance strap 386 is used with the walker 300, the dorsalshell 304 cannot be moved away from the base shell 302, preventingremoval of the walker 300 from the user's foot.

Locating the guide 382 on the anterior aspect can help increase theusability of the guide 382. For instance, when the walker 300 is placedon a user by a medical professional, the medical professional istypically situated in front of the walker 300. The position of thecompliance strap guide 382 on the anterior aspect of the proximal member362 allows the medical professional to more easily install a compliancestrap on the walker through the guide 382. This also allows thecompliance strap guide 382 to be positioned such that it will not rubagainst and/or damage an unaffected limb of the user during use of thewalker 300.

The compliance strap 386 can comprise a strap including high-densitypolyethylene fibers (e.g., a Tyvek® strap) arranged through thecompliance strap guide 382 and irreversibly attached to itself via anadhesive such that the compliance strap cannot be removed from thewalker 300 by sliding the compliance strap up and over the walker 300.The compliance strap 386 can only be removed by cutting or damaging thestrap 386, preventing removal of the walker without a clinician ormedical professional knowing. It will be appreciated that that thecompliance strap guide 382 and the compliance strap 386 are exemplaryonly, and other suitable configurations are possible. For instance, thebase shell 302 can include a recess or other feature suitable to receivea compliance strap.

Another exemplary embodiment of a compliance strap assembly 484 is shownin FIG. 11-13. The compliance strap assembly 484 can include acompliance strap 486 and a compliance clasp 488. The compliance strap486 can be formed of any suitable material such as, but not limited to,nylon and/or high-density polyethylene fibers.

The compliance clasp 488 can include a base member 490 and a door member492 pivotally attached to one another. A living hinge 494 can be formedbetween the base member 490 and the door member 492. The living hinge494 can be arranged to allow a clinician or medical professional toclose the compliance clasp 488 with one hand applying tension to thecompliance strap 486 and the other hand bringing the door member 492 andthe base member 490 together. Alternatively, the base member 490 can beformed as a separate piece from the door member 492 and pivotallyattached thereto in any suitable manner.

The base member 490 and the door member 492 can exhibit any suitableconfiguration. For instance, each of the base member 490 and the doormember 492 can exhibit a generally rounded rectangular shape having aperiphery, an upper surface area, and a lower surface area. In otherembodiments, the base member 490 and the door member 492 can exhibit agenerally triangular shape, a generally diamond shape, a generally ovalshape, combinations thereof, or any other suitable shape.

A pair of strap guides 496 can be formed on the upper surface of thebase member 490 for receiving an end portion of the compliance strap486. The strap guides 496 can be arranged to maintain alignment of thecompliance strap 486 with the compliance clasp 488, reducing thelikelihood that the compliance strap 486 will interfere with the doormember 492 in a closed position described below.

A receiving loop 498 can also be formed on the base member 490 forproviding an attachment point for one end of the compliance strap 486.This advantageously allows the one end to be attached to the receivingloop 498 and the other end of the compliance strap 486 to be loopedthrough a compliance strap guide (e.g., guide 382), around the walker(e.g., walker 300), through the strap guides 496, and attached toitself.

Referring to FIGS. 12 and 13, a plurality of recesses 401 can be formedin the upper surface of the base member 490. A plurality of spike-likeprotrusions 403 can be formed on the lower surface area of the doormember 492 that correspond to the plurality of recesses 401. Thespike-like protrusions 403 can include a wider base portion 403A,providing additional strength to the spike-like protrusions 403.

The compliance clasp 488 can be moveable between an open position (shownin FIG. 12) in which the door member 492 is rotated away from the basemember 490, and a closed position in which the lower surface area of thedoor member 492 is rotated onto the upper surface area of the basemember 490. When the compliance clasp 488 is in the closed position, thespike-like protrusions 403 penetrate the recesses 401 to lock or graspthe portion of the compliance strap 486 extending between the basemember 490 and the door member 492 within the compliance clasp 488.

The spike-like protrusions 403 and the recesses 401 can be arranged inany suitable manner. The spike-like protrusions 403 and the recesses 401can be generally upright. The spike-like protrusions 403 and therecesses 401 can extend at one or more angles. For instance, thespike-like protrusions 403 and the recesses 401 can extend at one ormore angles configured to allow for limited one-way movement of thecompliance strap 486 with the compliance clasp 488 in the closedposition. This can allow a clinician or medical professional to tightenthe compliance strap 486 with the compliance clasp 488 in the closed orposition.

The spike-like protrusions 403 can be arranged to at least partiallypierce the compliance strap 486. Applying tension to the compliancestrap 486 when the compliance clasp 488 is in the closed position cantear the strap 486 or break one or more of the spike-like protrusions403. Thus, if a non-compliant patient removes the compliance clasp 488from the strap 486 to remove the walker 300, the clinician or medicalprofessional will know upon examination of the compliance assembly 484.

One or more detents 405 may be formed on and extend from the lowersurface of the door member 492. One or more locking grooves 407corresponding to the detents 405 can be formed in the upper surface ofthe base member 490. The locking detents 405 can engage the lockinggrooves 407 when the compliance clasp 488 is in the closed position,creating an irreversible closure.

This allows the compliance clasp 488 to be irreversibly locked in thelocking position, preventing a user from removing the compliance clasp488 from the strap 486 without breaking or damaging the strap 486 and/orthe compliance clasp 488. As seen, the detents 405 and the lockinggrooves 407 can be concealed within the compliance clasp 488 when thecompliance clasp 488 is in the closed position, preventing the user fromover-riding or tampering with the locking mechanism of the complianceclasp 488.

The compliance clasp 488 can be formed from any suitable material. Thecompliance clasp 488 can include metals, such as aluminum, carbon,composite materials, such as carbon fiber/epoxy composites, glassfiber/epoxy composites, or suitable plastic materials, such asthermoplastic or thermosetting polymers, fiber reinforced plastic,molded chopped fibers, or any other suitable material. Differentportions of the compliance clasp 488 can be formed from differentmaterials. For instance, one portion of the compliance clasp 488 can beformed form polypropylene (e.g., the living hinge) and another portioncan be formed by a metal insert (e.g., the spike-like protrusions).

While the door member 492 is described including the spike-likeprotrusions 403 and the base member 490 is described including therecesses 401, it will be appreciated that the door member 492 mayinclude the recesses and the base member 490 may include the spike-likeprotrusions. Moreover, it will be appreciated that the door memberand/or the base member may include any suitable numbers of spike-likeprotrusions and/or recesses. Further, the compliance clasp 488 caninclude any suitable feature to lock or grasp the compliance strap 486between the base and door members.

Another exemplary embodiment of a compliance clasp 588 is illustrated inFIG. 14. The compliance clasp 588 can be similar to the compliance clasp488, except that base member 590 includes a first plurality of teeth 501formed in the upper surface of the base member 590 and the door member592 includes a second plurality of teeth 503 of complementary shape inthe lower surface of the door member 592 for interlocking with the firstplurality of teeth 501 of the base member 590.

When the compliance clasp 588 is in the receiving position, thecompliance strap can easily slide through the strap guides 596 on thebase member 590 to adjust the location and/or tension in the strap. Whenthe compliance clasp 588 is moved into the closed position, the teeth501 of the base member 590 engage the teeth 503 of the door member 592to lock or grasp the compliance strap within the compliance clasp 588.Similar to the compliance clasp 488, the compliance clasp 588 caninclude detents 505 and locking grooves 507 arranged to irreversiblylock the compliance clasp 588 in the closed position.

Another exemplary embodiment of a walker 600 is shown in FIGS. 15-28.The walker 600 can be similar to the walker 100 except that the walker600 includes an inflation system 601 arranged to reduce pressure pointswithin the walker 600, accommodate different sized anatomies, and/or toaccommodate swelling.

As can be seen from FIGS. 15 and 16, the walker 600 includescomplementary base shell 602 and dorsal shell 604 and a plurality ofstraps 654 arranged to bring the base shell 602 and the dorsal shell 604closer together. The plurality of straps 654 can include an ankle strap654A, an upper strap 654B, and a foot strap 654C. A soft good liner 612can be provided inside the base shell 602 and the inflation system 601can be integrated on the interior and/or the exterior of the walker 600.

For simplicity, FIG. 17 shows the inflation system 601 removed from thewalker 600 according to an embodiment. The inflation system 601 caninclude a pump assembly 603, one or more inflation tubes 605, and aninflatable bladder 607. The inflatable bladder 607 can be arranged in anankle receiving portion of the walker 600 (best shown in FIG. 27) andinflated and/or deflated via the one or more inflation tubes 605, whichare in fluid communication with the pump assembly 603. Optionally, theinflation system 601 can include a pressure relief valve assembly 609that can automatically expel excess air from the inflation system 601,reducing the likelihood of over-inflation that can harm the user.

As best shown in FIGS. 15 and 20, the pump assembly 603 can be connectedto the inflation tube 605 and can be attached to and/or carried by theupper strap 654B. Arranging the pump assembly 603 on the upper strap654B can allow the pump assembly 603 to be in a relatively fixedposition with respect to the base shell 602. As the location of thedorsal shell 604 moves up and down as a user moves or to accommodatevariations in user anatomy, the position of the pump assembly 603relative to the base shell 602 can remain substantially fixed on theupper strap 654B. This has the effect of preventing kinking of theinflation tubes 605 and/or unwanted movement of the pump assembly 603that could inadvertently inflate or deflate the inflatable bladder 607.Arranging the pump assembly 603 on the upper strap 654B on the anteriorof the walker 600 can also make the pump assembly 603 more usable andaccessible to a user.

Optionally, the pump assembly 603 can be permanently attached to thestrap 654B so that the pump assembly 603 is not easily misplaced. Theupper strap 654B may be generally flexible, allowing the pump assembly603 to generally conform to the shape of the dorsal shell 604 below thestrap 654B, regardless of the anterior and/or posterior position of thedorsal shell 604 relative to the strap 654B.

It will be appreciated that the location of the pump assembly 603 on theanterior region of the upper strap 654B is exemplary only, as othersuitable locations of the pump assembly 603 are possible. For example,the pump assembly 603 can be located on the ankle strap 654A. The pumpassembly 603 can be arranged on the lateral region of the upper strap654B or the exterior of the base shell 602 in the lower leg region ofthe walker 600.

As seen in FIG. 18, the pump assembly 603 can include a cover 611, apump 613, a fill valve 615, and a release valve 617. The cover 611 canbe arranged to house the pump 613, the fill valve 615, and the releasevalve 617. The cover 611 can exhibit any suitable configuration. Thecover 611 can be made from any suitable flexible, resilient, orcompliant material. The cover 611 can include one or more vent openingsto allow air vented from the inflatable bladder 607 to pass through thecover 611 to the atmosphere.

Optionally, the cover 611 can include one or more enhancement features619, such as raised or recessed portions, which can be configured in anysuitable design. For example, the enhancement features 619 may beconfigured as a cross “+” indicating inflation and an elongated recess“−” indicating deflation. The enhancement features 619 can also helpenhance function and/or gripping so that a user can more easily actuatethe pump 613 and/or the release valve 617. The enhancement features 619can also provide visual and/or tactile indicators for the user. Thecover 611 can further include one or more features to wrap around thestrap 654B for better securement of the pump assembly 603 to the strap654B. As noted above, the cover 611 can exhibit any suitableconfiguration.

The pump 613 is housed within the pump cover 611 and can comprise anysuitable pump type. For example, the pump 613 can be a diaphragm orpositive displacement pump including a diaphragm or body 621, an inlet623, and an outlet 625. The inlet 623 can be formed in one end of thebody 621 and can allow air to flow into the body 621. The inlet 623 canalso be selectively closed when the pump 613 is actuated so that airdoes not flow out of the pump 613 through the inlet 623. Optionally, theinlet 623 can be arranged as a release valve or the pressure reliefvalve described below. The outlet 625 can be opposed to the inlet 623 onthe other side of the body 621. A one-way valve assembly 627 can beprovided within the outlet 625 for allowing air to pass from the pump613 into the inflatable bladder 607, but not from the inflatable bladder607 to the pump 613.

In operation, when the diaphragm or body 621 of the pump 613 moves up(e.g., volume increases), pressure within the pump 613 decreases,causing air to be drawn into the pump through the inlet 623. When thebody 621 of the pump 613 moves down (e.g., volume decreases), thepressure in the pump 613 increases, forcing the air that was previouslydrawn in out of the pump 613 through the outlet 625. Finally, the body621 moving up once again draws air into the pump 613.

The pump 613 can have any suitable shape and size. For instance, thepump can include a generally box-like shape with a convex anterior sideand/or a convex posterior side. The shape of the pump can be arranged tomaximize the useable stroke volume of the pump 613.

The release valve 617 can be arranged to selectively release pressurewithin the inflatable bladder 607 and/or the inflation system 601. Therelease valve 617 can be incorporated with the pump 613. The releasevalve 617 can be incorporated with the pump assembly 603. The one-wayoutlet valve assembly 627 can communicate with the inflatable bladder607 via the release valve 617. The release valve 617 can be activatedmanually by a user. The release valve 617 can be separate from the pumpassembly 603. The release valve 617 can be located at any suitablelocation on the walker 600.

Alternatively, the pump 613 and/or release valve 617 can be electricallypowered by a portable power source associated with the walker 600. Thepump 613 can be configured to be usable with fluid or liquid. Forexample, the pump 613 can be usable with liquid to provide hot and/orcold therapy.

FIG. 19 illustrates a pump assembly 703 according to another embodiment.The pump assembly 703 can include a pump 713 having an elongatedovoid-like shape including a maximum dimension between the anterior andposterior sides at a center of the pump 713 that tapers toward each endof the pump 713. A larger, more elongate cover 711 can cover the pump713 and a release valve 717. The shape of the pump 713 can be arrangedto maximize the useable stroke volume of the pump 713.

As seen in FIG. 20, a tube hole 662 can be formed in the proximal wingportion 610 of the base shell 602 for receiving the inflation tube 605exiting the pump assembly 603. The tube hole 662 can exhibit anysuitable configuration. The tube hole 662 can comprise a semi-ellipticalrelieved portion or cutout on a strap slot 656 in the proximal portionof the wing portion 610. The tube hole 662 can be separate from thestrap slot 656. The tube hole 662 can be elongated, circular, or canexhibit any other suitable shape. While one tube hole 662 is shown inthe wing portion 610, in other embodiments, two, three, four, or anyother number of tube holes 662 are possible.

The inflation tube 605 exiting the pump assembly 603 can be threadedfrom the interior of the base shell 602 through the tube hole 662. Fromthe tube hole 662, the inflation tube 605 is guided or routed along theexterior of the base shell 602 to the posterior aspect of the base shell602 where it is connected to the pressure relief valve assembly 609(shown in FIG. 21), positioned under a cover member 664 attached to theposterior aspect of the base shell 602.

The inflation tube 605 can be flexible so that the inflation tube 605can generally conform to the contour of the base shell 602. Theinflation tube 605 can include one or more segments sized and shaped togenerally contour the exterior of the base shell 602. For example, atleast one of the segments of the inflation tube 605 can include one ormore bends that generally contours the bends or curves in the exteriorof the base shell 602. In other embodiments, the inflation tube 605 canbe routed in grooves formed on the interior surfaces of the base shell602.

A fabric sleeve 628 can be located on the upper strap 654B for guidingthe inflation tube 605 along the outside of the base shell 602 from thepump assembly 603 to the pressure relief valve assembly 609 within thecover member 664. The fabric sleeve 628 can comprise a unitary sleeve ora plurality of discrete portions of the sleeve 628. The fabric sleeve628 can comprise an integrated portion of the upper strap 654B. Forinstance, the fabric sleeve 628 can comprise vertical cutouts in theupper strap 654B into which the inflation tube 605 can be interwoven.

Routing the inflation tube 605 on the outside of the base shell 602 canhelp reduce or eliminate pressure points on the interior or inside ofthe walker 600, which can be both uncomfortable as well as a risk forresulting in pressure ulcers. Further, routing the inflation tube 605 onthe outside of the base shell 602 protects the inflation tube 605 frombeing pinched or compressed between the interior of the walker 600 andthe leg of the user.

It will be appreciated that the inflation tube 605 can exit the pumpassembly 603 in any suitable manner. For example, the inflation tube 605can be routed in one or more indentations or grooves formed in theexterior or interior surface of the base shell 602. The inflation tube605 can be routed through guides (e.g., rings or clips) attached to theexterior of the base shell 602, between the upper strap 654B and theexterior of the base shell 602, or in any other suitable arrangement.

For simplicity, FIG. 21 is a partial view of the posterior of the baseshell 602 with the cover member 664 removed. As shown, the inflationtube 605 connects to the pressure relief valve assembly 609, which ishoused within a cavity or cutout 631 formed in the base shell 602. Thecutout 631 can have any suitable configuration. The cutout 631 canextend completely between the interior and exterior surface of the baseshell 602. The cutout 631 can have a generally rectangular shape, agenerally trapezoidal shape, a shape that generally corresponds to theshape of the pressure relief valve assembly, or any other suitableshape.

A pair of strap slots 656 can be formed on opposing sides of the cutout631. The upper strap 654B can pass from the exterior of the base shell602 and through a strap slot 656, situating the upper strap 654B behindthe pressure relief valve assembly 609. The strap 654B can then extendthrough the other strap slot 656 back to the exterior of the base shell602. This allows the strap 654B to form a protective barrier between thepressure relief valve assembly 609 and the user's leg.

The cover member 664 can be attached the base shell 602 over the cutout631 and the pressure relief valve assembly 609. The cover member 664 caninclude a base portion 633 and a peripheral sidewall 635 arranged toextend from the base portion 633 toward the base shell 602 of the walker600.

A recess 639 in the cover member 664 is bounded the sidewall 635 and thebase portion 633 so that the bottom of the recess 639 is above (recessedwithin) the rim 637 of the sidewall 635 to provide a space for thepressure relief valve assembly 648. This can allow the base portion 633and the sidewall 535 to substantially enclose the pressure relief valveassembly 609 within the recess 639, protecting the pressure relief valveassembly 609 within the cutout 631 and helping to deter tampering.

The sidewall 635 defines a rim 637 extending around the base portion633. At least a portion of the rim 637 can be contoured to generallycorrespond to the contour of the posterior of the base shell 602. Thiscan allow the cover member 664 to form a better fit between the covermember 664 and the base shell 602. The rim 637 can also provide asupport area for the cover member 664 when the cover member 664 isattached to the base shell 602. Optionally, one or more ribs 643 can beformed on the rim 637 arranged to crush during attachment of the covermember 664 to the base shell 602 to accommodate variations in thegeometry of the base shell 602.

One or more side openings 641 can be formed along the rim 637 of thesidewall 635 for accommodating a portion of the inflation tubes 605. Oneside opening 641 can be arranged to accommodate a portion of theinflation tube 605 extending between the pump assembly 603 and thepressure relief valve assembly 609. Another side opening 641 can bearranged to accommodate a portion of the inflation tube 605 extendingbetween the pressure relief valve assembly 609 and the inflatablebladder 607.

The cover member 664 can be attached to the base shell 602 in anysuitable manner. The cover member 664 can be secured to the base shell602 via a snap-type connection. The cover member 664 can include aplurality of snaps or hook members 629 integrally formed in the sidewall635 and configured to snap into the cutout 631 formed in the base shell602, facilitating assembly. The cover member 664 can be attached to thebase shell 602 via gluing or plastic welding. Alternatively, the covermember 664 can be removably attached to the base shell 602 viafasteners, hook-and-loop type systems, clips, magnets, or any othersuitable attachment system.

By arranging the pressure relief valve assembly 609 within the cutout631 and cover member 664, the pressure relief valve assembly 609 can beprotected from damage due to accidental contact with external objects.Moreover, the cover member 664 can help limit or eliminate pressurepoints from components of the inflation system 601 (e.g., the pressurerelief valve assembly). The cover member 664 can be used with othercomponents of the inflation system 601. The cover member 664 can also beinterchangeable based on needs for various indications such as anadjustable relief valve or housing an activity monitor.

The location of the pressure relief valve assembly 609 on the posteriorof the base shell 602, helping to deter tampering. In other embodiments,the pressure relief valve assembly 609 can be incorporated in theinflatable bladder 607, on the lateral side of the base shell 602, or inany other suitable position.

The pressure relief valve assembly 609 can exhibit any suitableconfiguration. Referring now to FIGS. 22 and 23, the pressure reliefvalve assembly 609 can comprise a pressure relief valve 643 including avalve body 645 having a first port 647, a second port 649, and a thirdport 651. A first fluid pathway 653 connects the second port 649 and thethird port 651. A second fluid pathway 655 connects the first fluidpathway 653 and the first port 647. The first port 647 of the valve body645 is connected to the inflation tube 605 extending between the pumpassembly 603 and the pressure relief valve 643. The second port 649 isconnected to the inflation tube 605 extending between the pressurerelief valve 643 and the inflatable bladder 607. As seen, the first port647 can be at about a 90 degree angle relative to the second port 649.

The first port 647 and the second port 649 can be connected to theinflation tubes 605 in any suitable manner. For example, in theillustrated embodiment, the first port 647 and the second port 649 canbe connected to the inflation tubes 605 via a barb-type connection. Theinflation tubes 605 can be attached to the pressure relief valve 643 viasolvent bonding, friction or spin welding, adhesives such as a UV cureadhesive, or any other suitable attachment means.

The valve body 645 further includes an upper portion 657 that can haveany suitable configuration. The upper portion 657 comprises a generallycylindrical member including a bottom opening that is in fluidcommunication with the third port 651 and one or more vent openings 659in the side thereof for venting air to the atmosphere. The bottom of theupper portion 657 can include a surface surrounding a bottom openingthat forms a valve seat 661 for a sealing member 663.

The upper portion 657 is generally hollow, providing a space for thesealing member 663. The sealing member 663 can comprise an elastomericdisk having a diaphragm shape or an umbrella shape positioned within theupper portion 657. The sealing member 663 can comprise a disk having agenerally Belleville spring washer shape that includes stem portion 665.An upstream side of the sealing member 663 can be situated within thefirst fluid pathway 653 and a downstream side can be situated betweenthe sealing member 663 and a retainer member 667. The sealing member 663can be formed from any suitable material such as silicone and/or otherelastomeric materials.

The retainer member 667 is arranged to retain the sealing member 663within the upper portion 657 of the valve body 645. The retainer member667 can comprise a generally cylindrical member including a stem havinga recessed or hollow portion configured to receive and hold the stemportion 665 of the sealing member 663 in place.

The retainer member 667 may be a separate component from the valve body645. The upper portion 657 can include a plurality of detents or catches671 and the retainer member 667 can include a plurality of correspondinglocking apertures 673 extending between the top and bottom surface ofthe retainer member 667. The locking apertures 673 can engage thedetents 671 of the upper portion 657 when the retainer member 667 ispositioned on the upper portion 657 so that the retainer member 667snaps over the upper portion 657 of the valve body 645 and is lockedthereon.

Raised portions 675 can be situated between the detents 671, providing asupport surface for the retainer member 667 when the retainer member 667is snapped over the upper portion 657. This arrangement can help ensurethat the distance from the valve sealing surface to the retainer member667 is controlled, which acts to control compression of the sealingmember 663 and thereby the valve cracking pressure. Alternatively, theretainer member 667 may be integral to the valve body 645. For example,the retainer member 667 could be integrated into the valve body 645 viaa hinged snap.

The pressure relief valve 643 is movable between the closed position,wherein the third port 651 is sealed by sealing member 663, and the openposition, wherein the third port 651 is unsealed, such that air or otherfluids may flow, from the inflatable bladder 607 and/or pump 613 throughthe first and second fluid pathway 653, 655 to atmosphere.

When the sealing member 663 is mounted in the valve seat 661, thesealing member 663 can have a generally convex shape that flattens outagainst the valve seat 661 to create a certain sealing force thatmaintains the pressure relief valve 643 in the closed position. Thesealing member 663 can use at least in part its elastic materialproperties and its preloaded convex shape to create the sealing forceagainst the valve seat 661.

When the internal pressure within the inflation system 601 or headpressure creates enough force to lift or pop the sealing member 663 fromthe valve seat 661 of the upper portion 657, the third port 651 isunsealed and air can be vented from the inflatable bladder 607 and/orinflation system 601 to atmosphere. The stem 665 of the sealing member663 positioned within the retainer member 667 can form a hinge aboutwhich disc portion of the sealing member 663 pops between its convexshape and a more flattened or concave shape in which the disc portion ofthe sealing member 663 lifts away from the valve seat 661 of the upperportion 657.

The pressure at which the sealing member 663 lifts off of the valve seat661 is called the cracking pressure. When the head pressure is less thanthe cracking pressure, the sealing member 663 can automatically pop backclosed. The cracking pressure of the pressure relief valve 643 can begreater than about 40 mmHg, about 50 mmHg, about 55 mmHg, about 60 mmHg,or about 65 mmHg. In other embodiments, the cracking pressure of thepressure relief valve 643 can be between about 40 mmHg and about 70mmHg, about 45 mmHg and about 65 mmHg, or about 50 mmHg and about 60mmHg. In other embodiments, the cracking pressure may be greater orlower. The cracking pressure of the pressure relief valve 643 can be setor varied by varying the shape and/or elastomeric properties of thesealing member 663.

The cracking pressure of the pressure relief valve 643 can be selected,set, or adjusted to generally correspond to a selected pressure limitwithin the inflatable bladder 607. The selected pressure limit cancomprise a safe operating pressure, a therapeutic pressure, an activityspecific pressure, a treatment pressure, or any other suitable pressurelimit.

Alternatively, the retainer member 667 can be threadedly attached to theupper portion 657 of the valve body 645 such that the height of theretainer member 667 relative to the sealing member 663 can be adjusted,which, in turn, can influence the cracking pressure of the sealingmember 663 by adjusting the force exerted on the sealing member 663 bythe retainer member 667. Thus, the cracking pressure can be adjusted byadjusting the position of the retainer member 667 relative to thesealing member 663. The cracking pressure adjustment can be made by theuser based on their activity level. For instance, a higher pressuresetting could be used for periods of high activity like walking, while alower pressure setting could be used for periods of rest.

In use, when the inflatable bladder 607 is inflated to point where theinternal pressure within the inflation system 601 or head pressure onthe sealing member exceeds the cracking pressure of the pressure reliefvalve 643, the pressure relief valve 643 can automatically move to theopen position, thereby expelling or releasing air from the inflationsystem 601 and/or inflatable bladder 607 to atmosphere through the thirdport 651 of the pressure relief valve 643. As air is released from theinflation system 601, the internal pressure within the inflation system601 can drop below the cracking pressure of the pressure relief valve643 such that the pressure relief valve 643 automatically returns to theclosed position, thereby resealing the inflation system 601.

Because the pressure relief valve 643 automatically limits or regulatesthe level of pressure within the inflation system 601, the pressurerelief valve 643 can reduce the likelihood that a user will over-inflatethe inflatable bladder 607. This is advantageous because users ofwalkers and other orthopedic devices, especially diabetic patients,often experience reduced sensation in their extremities, which canresult in them inadvertently over-inflating the inflatable bladder 607.Such over-inflation can cause pressure on the skin, which can reduceboth capillary blood flow to the skin and arterial flow to theanatomical member. Thus, by limiting or automatically regulating thelevel of pressure within the inflatable bladder 607 and/or inflationsystem 601, the pressure relief valve 643 eliminates or reduces thelikelihood of over-inflation that can harm the user.

In addition, the pressure relief valve 643 can automatically releaseexcess pressure within the inflation system 601 resulting from otherfactors, such as, for example, changes in ambient pressure due to achange in altitude. The pressure relief valve 643 also reduces the needfor users themselves to set or monitor safe pressure levels within theinflation system 601. For example, conventional inflation systems oftenrequire patients to monitor pressure in the system using a pressuregauge attached to a pump. However, many patients, especially diabeticpatients, do not see well enough to read the pressure gauge and pressuregauges are known to malfunction. Consequently, such patients tend toover-inflate the inflatable bladder causing injury to the patient. Byincluding the pressure relief valve 643 in the inflation system 601, thepatient/user can inflate the inflatable bladder 607 without the need ofreading a pressure gauge or the risk of over-inflation.

The configuration of the pressure relief valve assembly 609 describedherein is to be regarded as exemplary only, as any suitableconfiguration of the pressure relief valve assembly is possible. Forexample, the pressure relief valve 643 can be a spring-loadedover-pressure relief valve, a check valve, a swing-check valve, adiaphragm valve, a ball valve, luer check valves, miniature checkvalves, or any other suitable valve. In other embodiments, the pressurerelief valve 643 can include, but is not limited to the Series 500Miniature Check Valves, commercially available from Smart Products,Inc., Morgan Hill, Calif., which are incorporated herein, in theirentirety, by this reference. Of course, other pressure relief valves maybe employed.

Another exemplary embodiment of a pressure relief valve assembly 709 isillustrated in FIGS. 24 and 25. The pressure relief valve assembly 709can comprise a pressure relief valve 743 similar to the pressure reliefvalve 643, except that retainer member 767, upper portion 757, andsecond port 749 exhibit a different configuration. As seen, the upperportion 757 can comprise a hollow substantially cylindrical memberhaving a generally solid sidewall. The upper portion 757 can includevent openings 759 formed in the sidewall for venting air the atmosphere.The inner surface of the upper portion 757 can include a plurality ofcatches 771 formed thereon, each including a generally planar bottomsurface area and an angled upper surface area. The retainer member 767can comprise a disc-like member sized and configured to snap inside ofthe upper portion 757. When the retainer member 767 is inserted orsnapped into the upper portion 757 of the valve body 745, the planarbottom surface areas of the catches 771 can form a stop by engaging thetop surface of the retainer member 767 to lock the retainer member 767within the upper portion 757.

The valve body 745 includes a first port 747, a second port 749, and athird port 751. A first fluid pathway 753 connects the first port 747and the second port 749. A second fluid pathway 755 connects the firstfluid pathway 753 and the third port 751.

Another exemplary embodiment of a pressure relief valve assembly 809 andcover member 864 is illustrated in FIG. 26. The pressure relief valveassembly 809 includes a pressure relief valve 843, a fitting 877, arelief tube 879 connected to the pressure relief valve 843, and theinflation tube 605. The fitting 877 may have any suitable configuration.For example, the fitting 877 may be a tee-type fitting having a firstport, a second port, and a third port. The fitting 877 can include afirst fluid pathway may extend between the second port and the thirdport and a second fluid pathway extending between the first port and thefirst fluid pathway. In an embodiment, the first port of the fitting 877is connected to the inflation tube 605 extending between to the pumpassembly 603 and the fitting 877. The second port of the fitting 877 isconnected to the inflation tube 605 extending through a tube hole 662(shown in FIG. 27) and between the fitting 877 and the inflatablebladder 607. As shown, the inflation tube 605 can be routed such that itat least partially loops around the pressure relief valve assembly 609.The third port can be connected to the relief tube 879 extending betweenthe fitting 877 and the pressure relief valve 843.

The pressure relief valve 843 can exhibit any suitable configuration.For example, the pressure relief valve 843 can include a valve bodyhaving a valve seat, a first port 847, a second port 849, and a fluidpathway extending between the first port 847 and the second port 849.

The pressure relief valve 843 can include a sealing member configured tocooperate with the valve seat in order to seal the second port 849. Thepressure relief valve 843 is movable between a closed position, whereinthe second port 849 is sealed by the sealing member, and an openposition, wherein the second port 849 is unsealed, such that air mayflow, for example, from the inflatable bladder 607 and/or pump assembly603 to the atmosphere. The pressure at which the pressure relief valve843 moves to the open position is the cracking pressure. In anembodiment, the sealing member can be biased against the valve seat toseal the second port 849 with the aid of a resilient retainer member. Inother embodiments, the sealing member can be held within the valve bodyby a retainer member and the sealing member can be configured to sealthe second port 849 based on the material properties and/or shape of thesealing member.

The pressure relief valve 843 can include means to adjust the resilientforce applied to the sealing member, such as a dial on the posterior ofthe base shell 602. The dial may be positioned on the base shell 602,integrated with the cover member 664, or in any other suitable location.By adjusting the resilient force, the cracking pressure of the pressurerelief valve 843 adjusts. Thus, the dial may have different settingssuch as high pressure, medium pressure, and low pressure. A user,clinician, or medical professional can select, set, or adjust thecracking pressure to customize the inflation system 601 for differentusers and/or user needs.

The cover member 864 can be similar to the cover member 664 except thatthe cover member 864 is larger and includes a u-shaped inner wall 881formed on the bottom of the recess 839. The u-shaped inner wall 881 canbe arranged to provide additional support and/or protection to thepressure relief valve assembly 809. The u-shaped inner wall 881 mayinclude side openings 841 formed along the rim thereof arranged toaccommodate and/or receive the inflation tubes 605. The inner wall 881can also help align the cover member 864 with the base shell 602. Forinstance, the inner wall 881 can fit into a corresponding groove orrecess formed on the base shell 602. This arrangement can eliminate theneed of hook members or snaps to withstand transverse loading.

A plurality of hook members 829 can be formed on and extending from thebottom of the recess 839. The hook members 829 can be arranged toselectively snap into the cutout 631. As shown, at least one of the hookmembers 829 can provide a support or guide for the inflation tube 605extending between the fitting 877 and the inflatable bladder 607. Itwill be appreciated that the cover member 864 can exhibit any suitableconfiguration.

FIG. 27 illustrates the base shell 602 with the liner removed forsimplicity. As seen, the posterior of the base shell 602 can includeanother tube hole 662 formed in a bottom wall of the cutout 631 that isin communication with the interior of the walker 600. The tube hole 662can exhibit any suitable configuration.

The inflation tube 605 connecting the pressure relief valve assembly 609and the inflatable bladder 607 can be inserted through the tube hole 662to the interior of the base shell 602 where an indentation or groove 883can be formed for guiding the inflation tube 605 to the inflatablebladder 607. The groove 883 can have any suitable configuration. Forexample, the groove 883 can extend from the tube hole 662 to a pointbelow the terminal edge of the inflatable bladder 607.

Routing the inflation tube 605 through the groove 883 on the interior ofthe base shell 602 can help reduce or eliminate pressure points on theinterior of the walker 600, which can be both uncomfortable as well as arisk for resulting in pressure ulcers. Guiding the inflation tube 605 inthe groove 883 can also protect the inflation tube 605 from beinginadvertently crushed or pinched. In other embodiments, the inflationtube 605 can be covered or secured into the groove 883 using adhesivetape, a separate cover component, or any other suitable means. As seen,the inflatable bladder 607 can be arranged within the posterior of thebase shell 602 such that when the inflatable bladder 607 is inflated,the inflatable bladder 607 can support the lower leg, ankle, and/orfoot.

The inflatable bladder 607 can be arranged in the ankle receivingportion of the base shell 602 and generally shaped to correspond to theposterior, medial, and lateral side of the base shell 602. As notedabove, observation holes 652 can be formed in the wing portions 610 ofthe base shell 602, allowing for tactile and/or visual confirmation thatthe inflatable bladder 607 is properly inflating or inflated.

The inflatable bladder 607 can include a posterior portion 685 and wingportions 687. The inflatable bladder 607 can be formed of two sheets ofair impervious plastic material that is welded around the edges tocreate air chambers therebetween. Optionally, perspiration wickingmaterial can be applied to the surfaces of the inflatable bladder 607that are configured to contact the wearer's anatomy.

The inflatable bladder 607 can be attached to the base shell 602 and/orliner 612 by a hook-and-loop type system, a snap-fit system,combinations thereof, or any other suitable attachment system. Forexample, a portion of the inflatable bladder 607 can be covered with aloop material (e.g., UBL loop) to make it easily attachable to acorresponding hook material on the base shell 602. In other embodiments,the inflatable bladder 607 can snap into or onto the base shell 602.Welds and/or holes 689 can be arranged in the inflatable bladder 607 toserve a number of functions. For example, the welds 689 in theinflatable bladder 607 can be configured to direct airflow within theinflatable bladder and also to provide heat and perspiration wickingchannels along the surfaces of the inflatable bladder 607.

The inflatable bladder 607 can include a central opening 691 having anhour-glass like shape. The central opening 691 can be configured toreceive and support the Achilles tendon so that the lower leg fitssnugly within the walker 600, and the ankle is securely positionedwithin the walker 600. In other embodiments, the inflatable bladder 607may include longitudinally extending openings (not shown) that provideventing for heat and perspiration. Moreover, the posterior of theinflatable bladder 607 can include a bridge portion that includes aninlet for the inflation tube 605 and this is in fluid communication withthe lateral and medial sides of the inflatable bladder 607. Such aconfiguration can help the inflatable bladder 607 inflate more equally,reducing the likelihood that one side inflates faster than the otherside.

The shape of the inflatable bladder 607 can further be configured tofocus compression where it is needed and uniform compression is providedto areas of the anatomy where the inflatable bladder 607 providescompression. In other embodiments, the shape of the inflatable bladder607 can be configured to create specific areas of pressure off-loading.The inflatable bladder 607 can be encased within a fabric covering,providing increased comfort to a user.

It will be appreciated that while a single inflatable bladder isdescribed, the walker 600 can include any suitable number of inflatablebladders. For example, in an embodiment, the walker 600 can includeseparate medial, lateral, and dorsal bladders. Moreover, while theinflatable bladder is described being inflated with air, it will beappreciated that the inflatable bladder can be filled with any suitablematerial or fluid. For example, the inflatable bladder 607 can beselectively filled with gel, foam, water, silicone, combinations thereofof the like. Moreover, in other embodiments, the inflatable bladder 607can be included as part of a liner within the walker 600. In otherembodiments, the inflatable bladder 607 is separate from a liner withinthe walker 600. Such a configuration may facilitate removal the linerfor washing or replacement.

While the inflation system 601 is shown with the walker 600, it will beappreciated that the exemplary embodiments of the inflation system canbe incorporated and/or used with a number of different orthopedicdevices. For instance, exemplary embodiments of the inflation system canbe used with a short leg walker, an ankle walker, a strut walker, afracture walker, an Achilles walker, or any other suitable orthopedicdevice. In other embodiments, the inflation system 601 can be integratedwith a system providing Deep Vein Thrombosis (“DVT”) therapy.

In other embodiments, the inflation system 601 can be arranged tocontrol the amount of pressure within the inflation system 601 based onsensed conditions. As seen in FIG. 28, an inflation system 601Aaccording to another embodiment can include a pressure regulation system693 having a control unit 695 and one or more sensors 697 arranged tosense pressure within the inflatable bladder 607 and/or inflation system601 and to send one or more sensing signals 699 to the control unit 695.The sensing signals 699 can include information about pressure levelswithin the inflatable bladder 607 and/or inflation system 601. Thecontrol unit 695 can be operably connected to the pump 613 and therelease valve 617 and/or the pressure relief valve assembly 609 suchthat the control unit 695 can direct the pump the 613 to inflate theinflatable bladder 607 and the release valve 617 and/or the pressurerelief valve assembly 609 to deflate the inflatable bladder 607 inresponse to the pressure information received from the one or morepressure sensors 697.

For instance, the one or more sensors 697 can detect strain (ordeflection) due to pressure over an area in the inflatable bladder 607and/or the inflation system 601. The one or more sensors 697 can convertthis pressure energy to the one or more sensing signals 699 in the formof electrical energy. One or more analog-to-digital converters (ADC)convert the electrical energy to digital data that is provided to thecontrol unit 695. The ADC can be a separate component, can be integratedinto the control unit 695, or can be integrated into the one or moresensors 697. The control unit 695 can include processing hardware (e.g.,processing electrical circuitry) and an operating system configured torun one or more application software programs. The control unit 695 canuse one or more processing techniques to analyze the digital data inorder to determine pressure levels within the inflatable bladder 607and/or inflation system 601. Responsive to the one or more sensingsignals 699 output by the one or more sensors 697, the control unit 695(including control electrical circuitry) can direct the pump 613 toinflate the inflatable bladder 607 or the release valve 617 to deflatethe inflatable bladder 607, automatically controlling safe pressurelevels within the inflation system 601. In other embodiments, thecontrol unit 695 can direct the pressure relief valve assembly 609 todeflate the inflatable bladder 607 responsive to the one or more sensingsignals 699.

While various aspects and embodiments have been disclosed herein, otheraspects and embodiments are contemplated. The various aspects andembodiments disclosed herein are for purposes of illustration and arenot intended to be limiting. Additionally, the words “including,”“having,” and variants thereof (e.g., “includes” and “has”) as usedherein, including the claims, shall be open-ended and have the samemeaning as the word “comprising” and variants thereof (e.g., “comprise”and “comprises”).

1. A compliance assembly for use with an orthopedic device, thecompliance assembly comprising: a compliance strap arranged to engageand extend around an exterior of the orthopedic device; and a complianceclasp attached to the compliance strap, the compliance clasp including:a base member; a door member pivotally connected to the base member, thedoor member movable between an open position wherein the door member isrotated away from the base member and the compliance strap is movablebetween the base and door members, and a closed position, wherein thedoor member is rotated toward the base member and locks the compliancestrap between the base and door members; and a locking system arrangedto irreversibly lock the door member in the closed position.
 2. Thecompliance assembly of claim 1, wherein the locking system comprises oneor more detents on the door member and one or more locking grooves onthe base member corresponding to the one or more detents.
 3. Thecompliance assembly of claim 1, wherein the one or more detents areconcealed within the compliance clasp when the door member is in theclosed position to prevent tampering with the locking system.
 4. Thecompliance assembly of claim 1, wherein the one or more detents areformed on and extend from a lower surface of the door member.
 5. Thecompliance assembly of claim 4, wherein the one or more detents engageand lock in the one or more locking grooves when the door member is inthe closed position.
 6. The compliance assembly of claim 5, wherein theone or more detents and the one or more locking grooves are concealedwithin the compliance clasp when the door member is in the closedposition.
 7. The compliance assembly of claim 5, wherein the one or moredetents are irreversibly locked in the one or more locking grooves whenthe door member is in the closed position.
 8. The compliance assembly ofclaim 1, wherein the door member is arranged to at least in part piercethe compliance strap when the door member is in the closed position. 9.The compliance assembly of claim 1, wherein the base member defines aplurality of recesses and the door member defines a plurality of lockingmembers corresponding the recesses.
 10. The compliance assembly of claim9, wherein the locking members are arranged to penetrate the recessesand lock a portion of the compliance strap within the compliance claspwhen the door member is in the closed position.
 11. The complianceassembly of claim 9, wherein at least one of the locking members arearranged to break when a tension is applied to the compliance strap withthe door member in the closed position.
 12. The compliance assembly ofclaim 9, wherein the locking members are formed of a metal material andthe door member is formed of a plastic material.
 13. The complianceassembly of claim 1, wherein the compliance clasp comprises a livinghinge formed between the base member and the door member.
 14. Thecompliance assembly of claim 1, wherein the base member defines a firstplurality of teeth and the door member defines a second plurality ofteeth arranged to engage with the first teeth of the base member whenthe door member is in the closed position.
 15. An orthopedic devicecomprising: a base shell having ankle and foot receiving portion, thebase shell forming an opening over a dorsal aspect thereof; a dorsalshell contoured to generally correspond to the opening of the baseshell; a compliance strap arranged to extend over the dorsal shell andaround a posterior of the base shell; a compliance clasp attached to thecompliance strap, the compliance clasp including: a base member; a doormember pivotally connected to the base member, the door member movablebetween an open position wherein the door member is rotated away fromthe base member and the compliance strap is movable between the base anddoor members, and a closed position, wherein the door member is rotatedtoward the base member and locks the compliance strap between the baseand door members; and a locking system arranged to irreversibly lock thedoor member in the closed position.
 16. The orthopedic device of claim15, wherein the dorsal shell defines a compliance strap guide and thecompliance strap extends through the compliance strap guide such thatthe compliance strap is prevented from being slipped off of theorthopedic device.
 17. The orthopedic device of claim 16, wherein thecompliance strap guide is defined on an anterior aspect of the dorsalshell.
 18. The compliance assembly of claim 15, wherein the base memberdefines a plurality of recesses and the door member defines a pluralityof locking members corresponding the recesses.
 19. The complianceassembly of claim 18, wherein the locking members are arranged topenetrate the recesses and lock a portion of the compliance strap withinthe compliance clasp when the door member is in the closed position. 20.A compliance assembly for use with an orthopedic device including a baseshell and a dorsal shell contoured to generally correspond to an openingof the base shell, the compliance assembly comprising: a compliancestrap arranged to engage and extend around a posterior of the base shelland an anterior of the dorsal shell; and a compliance clasp attached tothe compliance strap, the compliance clasp including: a base member; adoor member pivotally connected to the base member, the door membermovable between an open position wherein the door member is rotated awayfrom the base member and the compliance strap is movable between thebase and door members, and a closed position, wherein the door member isrotated toward the base member and locks the compliance strap betweenthe base and door members; and a locking system arranged to irreversiblylock the door member in the closed position, wherein the locking systemcomprises one or more detents on the door member and one or more lockinggrooves on the base member corresponding to the one or more detents.